Manufacturing Engineer II

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Manufacturing Engineer II Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. The position of Manufacturing Engineer II is within our Infectious Disease Business Unit located in Scarborough, Maine. This role will be responsible for all Manufacturing Equipment and equipment quality/cost savings initiatives, improving efficiency through material and process improvement, reducing material processing costs, and participating in new product design. What You’ll Work On Develops processes based on product specifications and in consideration to process and test method capabilities. Evaluates process and design alternatives based on Design and Manufacturability (DFM) principles. Uses problem solving and statistical tools and make sound design recommendations. Manages program compliance with Quality requirements (i.e. Design Control, Process validation etc.). Can identify work environment issues (i.e. OSHA regulations, etc.). Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Conducts tests, collects and formats data, and assists in analysis of engineering studies (DOEs). Assists in startup of new equipment and execution of validation protocols. Participates in technical design reviews for process equipment and product design and requirements documents. Responsible for utilizing and maintaining the effectiveness of the quality system, including supporting Quality Incidents and CAPA investigations and actions. Analyzes raw material specifications to ensure appropriate features and limits are in place to support company manufacturing process. Evaluates company initiated raw material changes and coordinates appropriate testing and validation as required. Works to reduce costs in all areas of manufacturing by analyzing current equipment for process suitability and provides detailed plans for improvement. Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, procedures and other technical documents to insure compliant, efficient, and safe processes. Conducts preventative maintenance audits and compliance with SOPs, ISO, FDA and cGMP requirements. Researches engineering solutions to a diverse set of challenges in production and development. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Carries out duties in compliance with established business policies and procedures. Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies. Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job. Support department by performing related tasks as requested. Core Competencies Ability to manage multiple tasks and priorities simultaneously while maintaining accuracy and productivity Self‑motivated and proactive, with the ability to drive work forward and seek learning opportunities with minimal supervision Strong verbal and written communication skills, with the ability to adapt messaging for different audiences Analytical and problem‑solving skills, with the ability to break down complex issues and develop practical solutions Ability to work collaboratively as part of a team, valuing diverse perspectives and supporting shared goals Technical aptitude, including the ability to interpret technical instructions, diagrams, and data Working knowledge of mathematical and statistical concepts such as ANSI/AQL, probability, and basic statistics Exposure to financial concepts related to production or operations, including COGS, profitability, pricing, and inventory management Experience with data analytics, including data collection, analysis, and basic statistical evaluation Experience using computer‑aided design (CAD) or manufacturing software to support system or layout design Required Qualifications Bachelor's degree (BS) in Engineering or equivalent combination of education and experience. 3 years’ engineering experience in a manufacturing environment. Technical experience in mechanical, biomedical, industrial or chemical engineering. Experience in performing engineering calculations, controlled tests, statistical analysis. Experience in Microsoft Suites software. (Microsoft Excel, PowerPoint, Power BI, etc.)  Experience in change management principles and processes. PREFERRED QUALIFICATIONS: Prior experience working in a company operating under ISO, FDA, or similar quality systems or regulations. Familiarity with cGMP and ISO 13485 regulations and practices. Experience with statistical analysis software. (Minitab or JMP preferred) Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews. The base pay for this position is $61,300.00 – $122,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Engineering DIVISION: ID Infectious Disease LOCATION: United States > Scarborough : 10 Southgate Rd ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 10 % of the Time MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Wear ear plugs, Work in a clean room environment, Work in noisy environment Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter